Use of calcium to improve fertilisation in patients with previous poor fertilisation or failed fertilisation and in patients with poor sperm quality.

The effect of oocyte activation using a calcium ionophore on fertilisation and clinical pregnancy rate following intra-cytoplasmic sperm injection (ICSI) in patients with previous poor fertilisation or failed fertilisation and for patients with severe male factor infertility.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001225808

Enrollment

100

Registered

2012-11-20

Start date

2013-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Oocyte activation is characterised by a dramatic increase in intracellular calcium concentration followed by short high frequency calcium oscillations. This is triggered when the spermatozoa penetrates the egg. Without this calcium influx the oocyte will fail to fertilise. Many studies have shown that the fertilsation rate can be improved as well as embryo development and consequent implantation rates, by mimicking the physiological cell-signalling mechanism using an activation agent such as a calcium ionophore. We wish to use a commercially avaliable calcium ionophore, GM508 Cult-Active, supplied by Gynemed Germany to study this effect on our patients who have undergone a complete failed fertilization cycle or a reduced fertilzation cycle (< 50% of oocytes injected) or where severe male factor infertility is evident.

Interventions

GM508 Cult-Active- oocytes are placed into the 1.0% calcium ionophore (GM508 Cult-Active) for 15 mins following ICSI. The oocytes are then removed, washed in our normal culture media and returned to the culture drops as per PIVET protocol. Patients may opt to have this treatment as many times as they want

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

21 Years to 45 Years

Healthy volunteers

Inclusion criteria

All participants will be patients of PIVET Medical Centre and under the clinical management of one or more of the Fertility Specialists who work at PIVET. No outside patients will be involved in this study. Eligible patients must have had previous complete failed fertilisation, reduced fertilisation (<50%) or have severe male factor infertility (Sperm concentration < 2 x 106 million/ml, Sperm motility < 5% Strict criteria normal morphology < 4%). Patients with surgically collected sperm (epididymal collected sperm or testicular collected sperm) will also be included

Exclusion criteria

Any patients that has had fertilisation rate of greater than 50% in a previous cycle will be excluded

Outcome results